Amaze: a double-blind, multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of adding an ablation device-based maze procedure as an adjunct to routine cardiac surgery for patients with pre-existing atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) can be treated using a maze procedure during planned cardiac surgery, but the effect on clinical patient outcomes, and the cost-effectiveness compared with surgery alone, are uncertain. OBJECTIVES: To determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF. DESIGN: Multicentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial. Patients were randomised on a 1 : 1 basis using random permuted blocks, stratified for surgeon and planned procedure. SETTING: Eleven acute NHS specialist cardiac surgical centres. PARTICIPANTS: Patients aged ≥ 18 years, scheduled for elective or in-house urgent cardiac surgery, with a documented history (> 3 months) of AF. INTERVENTIONS: Routine cardiac surgery with or without an adjunct maze procedure administered by an AF ablation device. MAIN OUTCOME MEASURES: The primary outcomes were return to sinus rhythm (SR) at 12 months and quality-adjusted life-years (QALYs) over 2 years after randomisation. Secondary outcomes included return to SR at 2 years, overall and stroke-free survival, drug use, quality of life (QoL), cost-effectiveness and safety. RESULTS: Between 25 February 2009 and 6 March 2014, 352 patients were randomised to the control (n = 176) or experimental (n = 176) arms. The odds ratio (OR) for return to SR at 12 months was 2.06 [95% confidence interval (CI) 1.20 to 3.54; p = 0.0091]. The mean difference (95% CI) in QALYs at 2 years between the two trial arms (maze/control) was -0.025 (95% CI 0.129 to 0.078; p = 0.6319). The OR for SR at 2 years was 3.24 (95% CI 1.76 to 5.96). The number of patients requiring anticoagulant drug use was significantly lower in the maze arm from 6 months after the procedure. There were no significant differences between the two arms in operative or overall survival, stroke-free survival, need for cardioversion or permanent pacemaker implants, New York Heart Association Functional Classification (for heart failure), EuroQol-5 Dimensions, three-level version score and Short Form questionnaire-36 items score at any time point. Sixty per cent of patients in each trial arm had a serious adverse event (p = 1.000); most events were mild, but 71 patients (42.5%) in the maze arm and 84 patients (45.5%) in the control arm had moderately severe events; 31 patients (18.6%) in the maze arm and 38 patients (20.5%) in the control arm had severe events. The mean additional cost of the maze procedure was £3533 (95% CI £1321 to £5746); the mean difference in QALYs was -0.022 (95% CI -0.1231 to 0.0791). The maze procedure was not cost-effective at £30,000 per QALY over 2 years in any analysis. In a small substudy, the active left atrial ejection fraction was smaller than that of the control patients (mean difference of -8.03, 95% CI -12.43 to -3.62), but within the predefined clinically equivalent range. LIMITATIONS: Low recruitment, early release of trial summaries and intermittent resource-use collection may have introduced bias and imprecise estimates. CONCLUSIONS: Ablation can be practised safely in routine NHS cardiac surgical settings and increases return to SR rates, but not survival or QoL up to 2 years after surgery. Lower anticoagulant drug use and recovery of left atrial function support anticoagulant drug withdrawal provided that good atrial function is confirmed. FURTHER WORK: Continued follow-up and long-term clinical effectiveness and cost-effectiveness analysis. Comparison of ablation methods. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82731440. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 19. See the NIHR Journals Library website for further project information.

The role of the emphysema multidisciplinary team in a successful lung volume reduction surgery programme†.

OBJECTIVES: Lung volume reduction surgery (LVRS) for advanced emphysema is well established, with strong evidence from the National Emphysema Treatment Trial. However, there is still reluctance to offer the procedure, and many have looked for alternative, unproven treatments. The multidisciplinary approach has been well established in treatment of lung cancer and, more recently, in coronary artery surgery. We reviewed our practice to validate the role of our multidisciplinary team approach in our LVRS programme. METHODS: Our multidisciplinary approach employs respiratory physicians, radiologists and surgeons involved in case selection, who meet on a regular basis. Cases are selected on the basis of clinical presentation, imaging (radionuclide lung perfusion and computerized tomography) and respiratory physiology. Retrospective analysis of prospectively collected data on 633 patients referred for lung volume reduction surgery between July 1995 and July 2013. RESULTS: Six hundred and thirty-three patients (422 male) were referred for LVRS, of whom 253 [178 male; median age 61 years (range 37-79 years)] underwent 292 LVRS procedures.There were 268 video-assisted thoracoscopic surgical procedures, of which 13 were one-stage bilateral procedures and 37 required a staged second side. Overall median hospital stay was 13 (4-197) days, during which 11 patients died. Prolonged hospital stay was associated with increasing age and with duration of air leak, which in turn was associated with diffusion capacity and forced expiratory volume in 1 s. CONCLUSIONS: The outcomes of a successful LVRS programme are not only dependent on good surgical technique and post-operative care. Case selection and work-up by a dedicated multidisciplinary approach for emphysema patients plays an invaluable and integral part in an LVRS programme.

Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.

OBJECTIVES: The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term. BACKGROUND: Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients. METHODS: The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010. RESULTS: Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model. CONCLUSIONS: Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.

Preoperative intra aortic balloon pumps in patients undergoing coronary artery bypass grafting.

BACKGROUND: The intra aortic balloon pump (IABP) is a mechanical assist device which improves cardiac function. The device has a well-established place in algorithms for managing low cardiac output following cardiac surgery. There is increasing evidence that certain cardiac surgery patients benefit from a period of preoperative augmentation with the intra aortic balloon pump. OBJECTIVES: To determine the effect of the preoperative intra aortic balloon pump on mortality and morbidity in a number of different patients groups undergoing coronary artery bypass grafting. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 3, 2009), MEDLINE (2000 to August 2009), EMBASE (1998 to August 2009), BIOSIS previews (1969 to August 2009) and ISI Proceedings (1990 to August 2009) were searched. References and ongoing registers of studies were checked. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs) of any size or length were included. DATA COLLECTION AND ANALYSIS: Papers were assessed for inclusion by two authors independently and differences were settled by consensus with a third author. Date are presented in the form of odds ratios (OR) and 95% confidence intervals (CI). MAIN RESULTS: Six trials were included (five on-pump and one off-pump). This update adds the results of one further trial. Data from a total of 255 patients were included in the meta-analysis of mortality outcomes; all on-pump. Generally, the patients were considered as "high risk" and 132 were treated preoperatively with IABP and 123 served as controls. There were four hospital deaths in the intervention arm and 23 in the non-intervention arm (OR 0.18, 95% CI 0.08 to 0.41; P<0.0001). In a subgroup analysis, low cardiac index (<2.0 L/min/m(2)) was noted in 21 out of 105 patients in the treatment arm and 59 patients out of 88 in the non-treatment arm (OR 0.14, 95% CI: 0.08 to 0.25; P<0.00001). An off-pump versus on-pump analysis was not possible due to the limited number of off-pump studies. However a single well-conducted RCT suggested favourable effect of the preoperative IABP in off-pump patients. AUTHORS' CONCLUSIONS: Evidence suggests that preoperative IABP may have a beneficial effect on mortality and morbidity in specific high risk patient groups undergoing coronary artery bypass grafting, however there are many problems with the quality, validity and generalisability of the trials. However, the available evidence is not robust enough to extend the use of IABP to truly elective, high risk patients. Defining more precisely which patient groups may benefit would be the challenge for the future.

A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System frame and its application in patients with 1-year minimum follow-up.

AIMS: The optimal clinical protocol to detect fractures of transcatheter aortic valves is unknown. To the best of our knowledge, there are no published reports describing stent or frame fractures following transcatheter aortic valve implantation. The purpose of this study is two-fold: (1) to determine the optimal fluoroscopic protocol to identify potential fractures of the Medtronic CoreValve frame; and (2) to implement this protocol in the analysis of the fluoroscopic films of patients implanted with the CoreValve device with 1-year minimum follow-up. METHODS AND RESULTS: Considering the resolution of fluoroscopy (approximately 0.2 mm), we used a 0.2 mm diamond-cutter to create a single fracture in a single strut of two CoreValve frames. An intact CoreValve prosthesis was used as control. These prostheses were subsequently implanted in post-mortem heart specimens. A protocol involving still frames and rotational (left-right and cranial-caudal) fluoroscopic imaging was then applied to the heart specimens. The experimentally induced fractures were detectable on the rotational cine runs (left-right and cranial-caudal); in some of the fixed acquisition sequences, however, the fractures were undetectable. The fluoroscopic protocol was retrospectively applied to the films of 58 patients who underwent implantation with the CoreValve System between October 2005 and August 2008 and had at least 1-year follow-up. The mean and median follow-up times were 22 months and 24 months, respectively (range 12 to 36 months). Rotational cine films (only left-right lateral) were available in 39 patients (60%). No frame fractures of the CoreValve frame were identified. CONCLUSIONS: Rotational cine runs in the left-right and cranial-caudal directions should be mandatory in the clinical assessment of the structural integrity of the CoreValve frame. No frame fractures were identified in 58 patients implanted with the Medtronic CoreValve device with 2-year mean follow-up.

Staged bilateral lung volume reduction surgery - the benefits of a patient-led strategy.

OBJECTIVE: Lung volume reduction surgery (LVRS) is conventionally a one-staged bilateral operation. We hypothesised that a more conservative staged bilateral approach determined by the patient not the surgeon would reduce operative risk and prolong the overall benefit. METHODS: In a population of 114 consecutive patients who were identified as suitable for bilateral LVRS an initial cohort of 26 patients (15 male; 11 female, median age: 58 years) underwent one-staged bilateral surgery: 18 by median sternotomy and eight by video-assisted thoracoscopic surgery (VATS) (group OB). A subsequent cohort of 88 patients had unilateral VATS LVRS with the contralateral operation not scheduled until the patient requested this. Longitudinal follow-up included analysis of lung function, health status (SF 36) and survival. RESULTS: At a median follow-up of 2.8 (range: 0-9.9) years, staged bilateral LVRS was performed in 16 patients (10 male; 6 female, median age: 59 years) (group SB) at a median interval of 3.9 (range: 0.7-5.9) years after the first operation. Unilateral LVRS has been performed in 73 patients (43 male; 30 female, median age: 60 years) (group U). There were significant improvements in forced expiratory volume in 1s (FEV1) for 6 months in groups OB and U; in group SB there was a second improvement at 4 years (p<0.05). There were significant reductions in residual volume (RV) and total lung capacity (TLC) in groups OB and U for 2 years; in group SB there was a further significant reduction lasting up to 6 years in TLC (p<0.05) and RV (p<0.01). There were significant improvements in health status lasting up to 1 year in groups OB and U. However, in group SB these improvements lasted for 4 years in the domain of physical functioning and 6 years in the domains of social functioning and energy/vitality. There was no significant difference (p=0.07) in 30-day mortality among groups OB (7.7%), SB (13%) and U (4.1%). Similarly, there was no difference between groups OB and SB/U in 3-year survival (81% vs 77%) or 5-year survival (54% vs 66%). CONCLUSION: A staged bilateral approach to LVRS dictated by patients' perception of their condition appears to lead to a more prolonged overall benefit than one-staged LVRS without compromising survival.

Intestinal angiodysplasia and aortic valve stenosis: let's not close the book on this association.

The association between gastrointestinal (GI) bleeding due to angiodysplasia of the large intestine and calcific aortic stenosis (AS) has been a matter of debate. Recent studies suggest that this association is related to subtle alterations in plasma coagulation factors. von Willebrand factor is the strongest possible link between aortic stenosis and bleeding associated with GI angiodysplasia. Physicians should be aware of this entity when dealing with elderly patients presenting either with GI bleeding or with AS. A high index of suspicion and appropriate diagnostic procedures followed by prompt treatment could be life saving. Several questions related to the pathogenesis and optimal management remain unanswered. Aortic valve replacement appears to offer the best hope of long-term resolution of the bleeding, and should be considered in most cases. The association between chronic gastrointestinal bleeding in elderly patients and aortic stenosis becomes more relevant with the advent of transcatheter aortic valve implantation which can be offered even to elderly patients with comorbidities which could make conventional surgery impossible.

Two-center prospective randomized controlled trial of Blake versus Portex drains after cardiac surgery.

OBJECTIVE: To compare the efficacy of two drain types after cardiac surgery in a randomized controlled trial, with primary outcome measure being depth of pericardial effusion 3 to 5 days after drain removal. METHODS: A prospective randomized controlled trial was conducted at two university hospitals. A total of 199 patients undergoing first-time cardiac procedures were randomized at surgery to receive either small-bore flexible Blake drains (19F) or larger Portex drains (28F). Drains were removed according to the study protocol and patients underwent echocardiography 3 to 5 days after drain removal to measure residual pericardial effusion. RESULTS: Ninety patients received Blake drains and 109 patients received Portex drains. There were no statistically significant differences in preoperative variables between the groups. There was no difference in the number of drains inserted per patient between groups (Blake 2.1 +/- 0.4 vs Portex 2.0 +/- 0.5). Mean difference in size of pericardial effusion between groups was 1.96 mm (95% confidence interval -0.02, 3.95 mm), which did not exceed the predefined non-inferiority margin of 10 mm. There was no significant difference in the mean maximal hourly drainage rate between groups (Blake 94.7 mL vs Portex 123.1 mL; P = .070) or in the total drainage rates (Blake 541 mL vs Portex 679 mL; P = .066). Although the Blake group had a higher percentage of patients with detectable effusion (46.3% vs 27.4%; P = .011) than the Portex group, there was no difference in need for late drainage of pericardial effusions (1.1% vs 1.9%) or insertion of further chest drains (8.8% vs 7.2%). CONCLUSION: The performance of small-bore Blake drains is not inferior to that of standard Portex drains after cardiac surgery.

Aspire porcine bioprosthesis: ten years' experience.

BACKGROUND AND AIM OF THE STUDY: Clinical results of this multicenter study of the Aspire porcine valve were reported previously at eight years; the present report provides an update of valve performance to 10 years postoperatively. METHODS: A total of 749 patients (60% males; mean age 73+/-7 years) underwent implantation with the Aspire (Tissuemed) porcine bioprosthesis between 1991 and 2002, at three institutions. Follow up was complete for 98% of the cohort. The mean follow up period was 51.6+/-39.6 months (range: 0-181 months); total follow up was 3,159 patient-years (pt-yr). RESULTS: There were 617 aortic valve replacements (AVR), 96 mitral valve replacements (MVR) and 32 double valve replacements. There were 62 deaths (8.3%), one of which was valve-related. The late mortality rate was 9.3% per pt-yr (1.2%/pt-yr valve-related). Actuarial freedom from complications at 10 years was: thromboembolism 76+/-4% (2.6%/pt-yr); hemorrhage 73+/-4% (2.8%/pt-yr); structural valve deterioration (SVD) 96+/-2% (0.2%/pt-yr); non-structural deterioration 99+/-1% (0.1%/pt-y); prosthetic valve endocarditis 97+/-1% (0.3%/pt-yr); and reoperation 97+/-1% (0.4%/pt-yr). In patients aged >70 years, the 10-year actuarial freedom from SVD was 98+/-2% for AVR and 93+/-7% for MVR. Preoperative atrial fibrillation (AF) was a significant predictor of late mortality (p <0.001), thromboembolism (p = 0.05) and hemorrhage (p = 0.01). CONCLUSION: The Aspire porcine bioprostheses is a reliable choice for a tissue valve, for both the aortic and mitral positions, especially in patients aged >70 years. In elderly patients the presence of AF is a significant predictor of early and late mortality and morbidity.

Off-pump coronary artery bypass surgery.

Off-pump coronary artery bypass surgery has been adopted enthusiastically worldwide. However, despite more than 6 years' experience and refinement, many surgeons use it only sporadically and some hardly at all. This reluctance persists despite support for the procedure because of the lack of properly designed risk models and/or randomized studies. Although it has not been overwhelmingly shown that off-pump surgery is superior to the conventional on-pump procedure, the technique has its place in our specialty. It has been shown to be better for noncritical end points in selected patients in the hands of selected surgeons. That there are differences in surgical skill among surgeons is something we all know but rarely discuss in public. Until now, disparities in skill have been most salient with uncommon and extraordinarily challenging operations. Perhaps the off-pump procedure should be regarded as the "challenging" aspect of coronary artery bypass surgery, and self-restraint may need to remain in force if we are to continue to achieve the highest level of clinical excellence.

Intra-aortic balloon counterpulsation: variations in use and complications.

OBJECTIVE: To study variations in use of intra-aortic balloon counterpulsation (IABC) and their impact on complications by comparing aspects of its use in a Regional Cardiothoracic Centre with an international database. METHODS AND RESULTS: Indications, technique and complication rate in 764 consecutive patients treated with IABC from January 1998 to November 2001 (Group I) at the Regional Cardiothoracic Centre were compared with 24,555 consecutive patients from the international ("Benchmark") database (Group II). Patients in Groups I and II were of similar mean age (65.5 vs. 65.6 years) and predominantly males (77.1% vs. 66.9%). IABC-related complications were significantly less in Group I vs. Group II (3.93% vs. 7.04%, p<0.001), probably due to the increased use of smaller French size balloons (8f in Group I: 73.3% vs. Group II: 28.8%, p<0.001) and significantly less use of femoral artery sheaths (Group I: 91.2% vs. Group II: 20.4%, p<0.001) as well as less concomitant use of potent anti-thrombotic therapy (4.2% vs. 21.7%). By comparison to the international database only a minority of our patients were transferred in specifically for insertion of IABC (Group I: 1.3% vs. Group II: 22.8%, p<0.001) suggesting under-recognition of the potential value of IABC in haemodynamically compromised patients. CONCLUSION: In comparison to an international database, complications were significantly less after IABC at the regional cardiothoracic centre. There were far fewer patients referred specifically for IABC use. Indications, choice of appropriate device, technique of deployment and concomitant use of anti-platelet therapy varies and perhaps needs to be standardised internationally. Regular audit of any such large database is vital to ensure dissemination of potentially important messages it contains.

The increase in body mass index observed after lung volume reduction may act as surrogate marker of improved health status.

OBJECTIVE: To assess the effects of lung volume reduction surgery (LVRS) on body mass index (BMI). METHODS: Prospective data was collected on a series of 63 patients undergoing LVRS (bilateral in 22 patients, unilateral in 41 patients). Median age was 58 (41-70) years. The peri-operative effects of LVRS on BMI, lung function and health status (assessed by SF 36 questionnaire) were recorded at 3, 6, 12 and 24 months. RESULTS: We found an overall increase in BMI after LVRS, which was significant up to 2 years. These changes correlated with the changes in FEV1 (R = 0.3, P < 0.01 6 months after LVRS) and diffusing capacity for carbon monoxide (DLCO) (R = 0.5, P < 0.01 6 months after LVRS). At 6 months, when the best results in health status were found, the patients were divided in a responders group (improved SF 36 score) and a non-responders group (same or worse SF 36 score) for each of the 8 domains of the SF 36. In 6 domains the non-responders showed no increase in BMI. In 6 domains the responders showed a significant increase in BMI. CONCLUSION: LVRS significantly improves postoperative BMI, which correlates with improvements in DLCO and reflects changes in health status.

The long-term health status improvements seen after lung volume reduction surgery.

OBJECTIVES: To correlate the long-term changes in respiratory physiology, body mass index (BMI) and health status after lung volume reduction surgery (LVRS). PATIENTS/METHODS: From 1995 to 2002 77 patients; 48 male: 29 female, median age 59 (41-72) years, have undergone LVRS (simultaneous bilateral in 27; staged bilateral in 3; unilateral in 47). FEV(1), total lung capacity (TLC), residual volume (RV) and RV/TLC ratio were measured preoperatively and at 3 months, 6 months, 1 year, 2 years, 3 years and 4 years post surgery. At the same time interval health status was assessed by Euroquol and Short Form 36 (SF 36) questionnaires. Seventeen patients have died within 4 years of their operation (30 day mortality 5%). RESULTS: The changes in FEV(1) are only significantly improved for 1 year post LVRS, while the improvements in TLC and RV remain significant up to 3 years postoperatively. The improvements in BMI also persist for 3 years. The best scores in Euroquol and SF 36 are obtained 6 months after LVRS but are only significantly improved up to 1 year. CONCLUSION: The physiological effects of volume LVRS are lasting but initial improvements in health status decline more rapidly.

Mitral valve relpair and revascularization for ischemic mitral regurgitation: predictors of operative mortality and survival.

BACKGROUND AND AIMS OF THE STUDY: Surgery for ischemic mitral regurgitation (IMR) is required in 4-5% of patients subjected to coronary artery surgery, and may be challenging. The study aim was to determine outcome following mitral valve repair and myocardial revascularization for moderate-to-severe IMR. METHODS: A total of 102 patients (mean age 68+/-7 years) underwent mitral valve repair for IMR between 1998 and 2001 at the authors' unit. Among patients, 28 had acute and 74 chronic mitral regurgitation (MR). Valve repair was achieved with an annuloplasty ring in all 102 patients, while 99 underwent concomitant myocardial revascularization. Preoperatively, 69 patients had MR grade III-IV, 62 had CCS angina class III-IV, 59 were in NYHA class II-IV, 81 had impaired left ventricular function, and 10 were in cardiogenic shock. Follow up was 100% complete (mean 14+/-7 months; range: 0-38 months). RESULTS: Overall operative mortality was 8.8% (n = 9) (17.8% for acute IMR, 5.4% for chronic, p = 0.048). On multiple logistic regression analysis, cardiogenic shock (p = 0.028) was the only significant risk factor for operative death. There were 11 late deaths. Kaplan-Meier survival at one and three years was 82+/-4% and 79+/-4%, respectively. On Cox proportional hazards regression model, preoperative left ventricular end-systolic diameter (LVESD) >4.5 cm (p = 0.01) and NYHA class III-IV (p = 0.02) were independent adverse predictors of survival. Three patients required reoperation. Kaplan-Meier three-year freedom from reoperation was 97+/-2%. CONCLUSION: Surgery for IMR carries a considerable, but acceptable, operative risk and provides satisfactory freedom from reoperation and mid-term survival. Cardiogenic shock before surgery is the major determinant of an unfavorable in-hospital outcome. LVESD >4.5 cm and poor preoperative NYHA status limit the probability of late survival. The study results support early surgical intervention for IMR, before ventricular dilatation occurs.